Hinged Versus Conventional 8 Plate for Correction of Genu Valgum or Varum

Genu Valgum or Varum Clinical Trial

Official title:

Comparison of the Outcomes of the Treatment of Semiepiphysiodesis Using Hinged and Conventional 8-figure Plates: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03378206
• Other study ID #: XH-17-013
• Status: Not yet recruiting
• Phase: N/A
• First received: September 25, 2017
• Last updated: April 8, 2018
• Start date: May 1, 2018
• Est. completion date: August 31, 2020

Study information

• Verified date: April 2018
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Ziming Zhang, PhD
• Phone: +86 13651756906
• Email: zmzhang23[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the therapeutic effect of hinged 8-figure plate by comparing with the traditional 8-figure plate through a randomized controlled clinical trial by assessing the differences between preoperative and postoperative data.

The hypothesis is that the hinged 8 plate provides low complications that this treatment is as good as the traditional one.

Description:

Angular deformities of the lower limb is major clinical problems encountered in pediatric orthopedics. Deformities can be either valgus or varus and most commonly affect the knee joint, which may result in patella dislocation, gait instability and serious impact on the appearance and function of the lower limbs. Biomechanical studies and gait analysis found that genu varus increased medial articular surface pressure of the knee, while genu valgus increased lateral articular surface pressure, and both of them are the risk factors for osteoarthritis. Surgical treatment techniques include osteotomy and hemiepipysidesis. Osteotomy surgery is the gold standard for severe angular deformity or epiphyseal closed patients, but it was associated with lots of complications, including osteofascial compartment syndrome, neurovascular injury, deep soft tissue infection, nonunion and requiring a long recovery time. While, for patients whose epiphyseal is not closed, the traditional 8 plate hemiepipysidesis has fewer complications. However, it showed some problems in clinical applications, such as steel plate or screw broken. The investigators designed a new hinged 8 plate, which has two arms and a built-in hinge. Based on the previous studies, investigators designed the rotation of the two arms ranged from 155° to 170° to better fit the contour of the physis in all stages of angular correction. That automatic change can also disperse repeated stress on the surface of periosteum and perichondrium during walking. The plate had been tested on animal models that the use of the hinged plate and screw system may be a more reliable technique with minimal complications for correction of angular deformities of the lower limb.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: August 31, 2020
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

Inclusion Criteria:

1. Idiopathic genu valgus or varum

2. Without any treatment

3. lower limb mechanical axis over the tibial plateau in the range of 1/2;

4. Epiphyseal not yet closed, with more than 12 months of growth potential

Exclusion Criteria:

1. Physiological genu valgus or varum

2. Epiphyseal have closed or no growth potential

3. Pathological limb deformity(Blount disease, inflammation,trauma)

4. Other causes of lower limb angular deformity.

5. With surgical contraindications

Related Conditions & MeSH terms

• Epiphyseal Arrest, Lower Leg
• Genu Valgum
• Genu Valgum or Varum
• Growth; Arrested, Bone

Intervention

Device:
• hinged 8-figure plate
Hinged 8-figure plate has two arms and a built-in hinge. The rotation of the two arms ranged from 155° to 170° to better fit the contour of the physis in all stages of angular correction. That automatic change can also disperse repeated stress on the surface of periosteum and perichondrium during walking.
• conventional 8-figure plate
Conventional 8-figure plate is a widespread device to treat angular deformity of lower limbs with moderate successful rate. The device was designed based on the principle of tension band model. It consists of a plate and two screws (epiphyseal screw and metaphyseal screw).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

References & Publications (18)

Aslani H, Panjavy B, Bashy RH, Tabrizi A, Nazari B. The efficacy and complications of 2-hole 3.5 mm reconstruction plates and 4 mm noncanulated cancellous screws for temporary hemiepiphysiodesis around the knee. J Pediatr Orthop. 2014 Jun;34(4):462-6. doi — View Citation

BLOUNT WP, CLARKE GR. Control of bone growth by epiphyseal stapling; a preliminary report. J Bone Joint Surg Am. 1949 Jul;31A(3):464-78. — View Citation

Boero S, Michelis MB, Riganti S. Use of the eight-Plate for angular correction of knee deformities due to idiopathic and pathologic physis: initiating treatment according to etiology. J Child Orthop. 2011 Jun;5(3):209-16. doi: 10.1007/s11832-011-0344-4. E — View Citation

Burghardt RD, Herzenberg JE, Standard SC, Paley D. Temporary hemiepiphyseal arrest using a screw and plate device to treat knee and ankle deformities in children: a preliminary report. J Child Orthop. 2008 Jun;2(3):187-97. doi: 10.1007/s11832-008-0096-y. — View Citation

Burghardt RD, Kanellopoulos AD, Herzenberg JE. A technical note on improved instrumentation for Blount staple insertion. J Child Orthop. 2012 Aug;6(4):347-50. doi: 10.1007/s11832-012-0422-2. Epub 2012 Aug 9. — View Citation

Burghardt RD, Specht SC, Herzenberg JE. Mechanical failures of eight-plateguided growth system for temporary hemiepiphysiodesis. J Pediatr Orthop. 2010 Sep;30(6):594-7. doi: 10.1097/BPO.0b013e3181e4f591. — View Citation

Bylski-Austrow DI, Wall EJ, Rupert MP, Roy DR, Crawford AH. Growth plate forces in the adolescent human knee: a radiographic and mechanical study of epiphyseal staples. J Pediatr Orthop. 2001 Nov-Dec;21(6):817-23. — View Citation

Driscoll MD, Linton J, Sullivan E, Scott A. Medial malleolar screw versus tension-band plate hemiepiphysiodesis for ankle valgus in the skeletally immature. J Pediatr Orthop. 2014 Jun;34(4):441-6. doi: 10.1097/BPO.0000000000000116. — View Citation

Gottliebsen M, Rahbek O, Poulsen HD, Møller-Madsen B. Similar growth plate morphology in stapling and tension band plating hemiepiphysiodesis: a porcine experimental histomorphometric study. J Orthop Res. 2013 Apr;31(4):574-9. doi: 10.1002/jor.22276. Epub — View Citation

Gros DF, Milanak ME, Brady KT, Back SE. Frequency and severity of comorbid mood and anxiety disorders in prescription opioid dependence. Am J Addict. 2013 May-Jun;22(3):261-5. doi: 10.1111/j.1521-0391.2012.12008.x. — View Citation

Guzman H, Yaszay B, Scott VP, Bastrom TP, Mubarak SJ. Early experience with medial femoral tension band plating in idiopathic genu valgum. J Child Orthop. 2011 Feb;5(1):11-7. doi: 10.1007/s11832-010-0310-6. Epub 2010 Dec 8. — View Citation

Lee HJ, Oh CW, Song KS, Kyung HS, Min WK, Park BC. Guided growth with a noncannulated screw-plate system for angular deformity of the knee: a preliminary report. J Pediatr Orthop B. 2012 Jul;21(4):339-47. doi: 10.1097/BPB.0b013e3283547198. — View Citation

Lin TY, Kao HK, Li WC, Yang WE, Chang CH. Guided growth by a stainless-steel tubular plate. J Pediatr Orthop B. 2013 Jul;22(4):306-10. doi: 10.1097/BPB.0b013e32835bc42d. — View Citation

Schroerlucke S, Bertrand S, Clapp J, Bundy J, Gregg FO. Failure of Orthofix eight-Plate for the treatment of Blount disease. J Pediatr Orthop. 2009 Jan-Feb;29(1):57-60. doi: 10.1097/BPO.0b013e3181919b54. — View Citation

Sharma L, Song J, Felson DT, Cahue S, Shamiyeh E, Dunlop DD. The role of knee alignment in disease progression and functional decline in knee osteoarthritis. JAMA. 2001 Jul 11;286(2):188-95. Erratum in: JAMA 2001 Aug 15;286(7):792. — View Citation

Stevens PM. Guided growth for angular correction: a preliminary series using a tension band plate. J Pediatr Orthop. 2007 Apr-May;27(3):253-9. — View Citation

Wu Z, Zhao D, Zhao L, Liu J, Li H, Zhu J, Ma F, Porter DE. A comparison between a hinged plate and screw system and a conventional tension-band plate and screw system used for correction of an angular deformity of the lower limb: an animal study. J Orthop — View Citation

Zuege RC, Kempken TG, Blount WP. Epiphyseal stapling for angular deformity at the knee. J Bone Joint Surg Am. 1979 Apr;61(3):320-9. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The complications.	Surgery related complications including osteofascial compartment syndrome, neurovascular injury, deep soft tissue infection and so on will be observed until correction of deformity.	2 years
Secondary	The corrective rates of medial slope angle.	The angle of medial slope will be measured when reexamination until the correction of deformity, which was used to calculate the corrective rates.	2 years
Secondary	The corrective of Mechanical lateral distal femoral angle.	The corrective of Mechanical lateral distal femoral angle will be measured when reexamination until the correction of deformity. And investigators will calculating the change of this angle.	2 years
Secondary	The movement of two arms of the hinged plate.	The movement of two arms during the experiment will be noted by the changing of two arms angle when reexamination until the correction of deformity.	2 years
Secondary	The residual stress on the implants.	Residual stress (remaining stress of the sample after implant removal) at the rim of the metaphyseal screw hole will be measured using X-ray diffraction.	2 years